Oligometastatic DiseaseOli-PNCT02264379
Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma
An observational study of Oligometastatic Disease and Prostate Cancer, run by Technische Universität Dresden at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate the outcomes of patients treated with an high dose radiation regimen using either stereotactic hypofractionated or normofractionated radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease, Prostate Cancer
- What is being tested?
- normal fractionated irradiation and hypo fractionated irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2014to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oligometastases (1-5) and state after local therapy of prostate cancer
Who may be able to join
- Patient with good general condition (WHO 0-1)
- No comorbidities which limit the further life expectancy of the patient to <5 years (opinion of the physician)
- Histologically confirmed prostate cancer
- State after definitive local therapy, such as radical prostatectomy or definitive radiotherapy (even after neo-/-adjuvant hormone therapy, after postoperative radiotherapy)
- PSA relapse after primary therapy or radiological unique metastasis, present complete staging (up to 8 weeks old) by CT thorax/ abdomen/ pelvis and bone scan alternatively a hybrid imaging PET (positron emission tomography) (acetate PET, PET-PSMA, NAFL-PET) and CT / MRI is sufficient
- Imaging detection of individual metastases (up to 5, depending on the situation) that a Radiation therapy are available (histological confirmation of the MET is not required)
- No parallel participation to further clinical therapeutic trials to 4 weeks and after radiation
- Consent of the patient and written informed consent
Who cannot join
- severe comorbidity which limit the further life expectancy of the patient to <5 years (opinion of the physician)
- PSA in PSA relapse> 10ng/ml
- Ongoing androgen deprivation at the time of study inclusion
- not been carried out local therapy
- no histological confirmation of prostate cancer
- lack of compliance
- absence of consent of the patient
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Dresden, Saxony, 01307
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
Tübingen, 72016
About this study
Official title: Effectiveness and Toxicity of a Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma
The purpose of this study is to evaluate the outcomes of patients treated with an high dose radiation regimen using either stereotactic hypofractionated or normofractionated radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.
Read the detailed description
Study Groups:
If the patient found to be eligible to take part in this study, the patient will be assigned to a study group based on the size of the lesion(s) and the discretion of the responsible physician. Up to 71 patients will be enrolled in the study.
If the patient is treated with standard radiotherapy, the patient will receive 25 fractions of 2 Gy to the metastases, the treatment duration will be 5 weeks.
If the patient is treated with image-guided hypofractionated radiotherapy, the patient will receive 3 fractions of 10 Gy to the metastases, the treatment duration will be 1 week.
Radiation Planning and Treatment:
During all radiation treatments, the images that are taken during the treatment will be closely analyzed after treatment is over. The patient will have 3 to 25 radiation treatments per metastasis depending on the discretion of the responsible physician.
The rest of the radiation treatment planning and treatment delivery appointments will be unchanged. The dose given to the tumor and number of treatments the patient will receive, will be determined by the discretion of the responsible physician, and is not affected by taking part in this study.
Follow-Up Visits:
After the radiation treatment schedule ends, the patient will return for follow-up visits at the following time points:
- At 3 months
- Then, every 3 months for 1 year, and then
- 1 time a year after that, for as long as possible Additional follow up visits may be scheduled, if the responsible physician thinks they are needed.
At these visits, the following tests and procedures will be performed:
- Any updates to the medical history of the patient will be recorded and the patient will be asked about any side effects the patient may be having.
- The patient's performance status will be recorded.
- The patient's complete symptom questionnaires will be reviewed.
- The patient will have a clinical examination
- The patient will have follow-up imaging (such as an MRI) to check the status of the disease.
This is an observational study. Radiation therapy is delivered using CE-certified and commercially available methods.
- Conditions
- Oligometastatic Disease, Prostate Cancer
- Being tested
- normal fractionated irradiation, hypo fractionated irradiation
- Keywords
- Oligometastatic Disease, Prostate Cancer, Stereotactic Radiotherapy, androgensensitive
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal fractionated irradiationRadiation
25*2 Gy (once a day, 5 days a week)
hypo fractionated irradiationRadiation
3*10 Gy (once a day, 2-3 days a week)
| Study group | Role | What they receive |
|---|---|---|
| normal fractionated irradiation | Not described Receives: Radiation: normal fractionated irradiation | |
| hypo fractionated irradiation | Not described Receives: Radiation: hypo fractionated irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Toxicity at year 2 after ablatvie radiotherapy
The toxicity will be scored (CTCAE 4.03) at each follow up visit, the status will be recorded by clinical examination and radiological imaging.
Measured: 24 months after therapy
Secondary outcomes (5)
Early toxicity
The toxicity will be scored (CTCAE 4.03) at 3 months follow up visit, the status will be recorded by clinical examination and radiological imaging.
Measured: until day 90 after start radiotherapy
Quality of life (QLQ-C30 and QLQ-PR25) during Follow-up
QoL will be assessed with the QoL-Questionaires QLQ-C30 and QLQ-PR25 at baseline, 3, 12 and 24 months after treatment.
Measured: 24 months after end of therapy
Local control of irradiated tumor manifestations
The tumor response will be evaluated (RECIST) at follow up visit 3,12 and 24 months after end of treatment, the status will be recorded by clinical examination and radiological imaging.
Measured: 24 months after end of therapy
Therapy-free survival
Therapy-free survival will be assessed as time from start of radiation to start of systemic treatment or androgen deprivation. The status will be assessed at each follow-up visit.
Measured: 24 months after end of therapy
PSA relapse-free survival
PSA relapse-free survival will be assessed as time from start of radiation to PSA-rise more than 20% above baseline. PSA - value will be assessed by blood testing.
Measured: 24 months after end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2020
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Hölscher, Technische Universität Dresden
- Investigators
- Tobias Hölscher, Dr., Principal investigator, Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264379
- Sponsor's protocol ID
- STR - Oli-P - 2014
- Acronym
- Oli-P
- Status last verified
- Feb 2023
- First submitted
- 22 May 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Toxicity of a Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT02264379
- Acronym / sponsor ID
- Oli-P / STR - Oli-P - 2014
- Conditions
- Oligometastatic Disease, Prostate Cancer
- Keywords
- Oligometastatic Disease, Prostate Cancer, Stereotactic Radiotherapy, androgensensitive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the outcomes of patients treated with an high dose radiation regimen using either stereotactic hypofractionated or normofractionated radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.
Detailed description
Study Groups:
If the patient found to be eligible to take part in this study, the patient will be assigned to a study group based on the size of the lesion(s) and the discretion of the responsible physician. Up to 71 patients will be enrolled in the study.
If the patient is treated with standard radiotherapy, the patient will receive 25 fractions of 2 Gy to the metastases, the treatment duration will be 5 weeks.
If the patient is treated with image-guided hypofractionated radiotherapy, the patient will receive 3 fractions of 10 Gy to the metastases, the treatment duration will be 1 week.
Radiation Planning and Treatment:
During all radiation treatments, the images that are taken during the treatment will be closely analyzed after treatment is over. The patient will have 3 to 25 radiation treatments per metastasis depending on the discretion of the responsible physician.
The rest of the radiation treatment planning and treatment delivery appointments will be unchanged. The dose given to the tumor and number of treatments the patient will receive, will be determined by the discretion of the responsible physician, and is not affected by taking part in this study.
Follow-Up Visits:
After the radiation treatment schedule ends, the patient will return for follow-up visits at the following time points:
- At 3 months
- Then, every 3 months for 1 year, and then
- 1 time a year after that, for as long as possible Additional follow up visits may be scheduled, if the responsible physician thinks they are needed.
At these visits, the following tests and procedures will be performed:
- Any updates to the medical history of the patient will be recorded and the patient will be asked about any side effects the patient may be having.
- The patient's performance status will be recorded.
- The patient's complete symptom questionnaires will be reviewed.
- The patient will have a clinical examination
- The patient will have follow-up imaging (such as an MRI) to check the status of the disease.
This is an observational study. Radiation therapy is delivered using CE-certified and commercially available methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal fractionated irradiation | – | Radiation: normal fractionated irradiation |
| hypo fractionated irradiation | – | Radiation: hypo fractionated irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oligometastases (1-5) and state after local therapy of prostate cancer
Key inclusion criteria (8 listed)
- Patient with good general condition (WHO 0-1)
- No comorbidities which limit the further life expectancy of the patient to <5 years (opinion of the physician)
- Histologically confirmed prostate cancer
- State after definitive local therapy, such as radical prostatectomy or definitive radiotherapy (even after neo-/-adjuvant hormone therapy, after postoperative radiotherapy)
- PSA relapse after primary therapy or radiological unique metastasis, present complete staging (up to 8 weeks old) by CT thorax/ abdomen/ pelvis and bone scan alternatively a hybrid imaging PET (positron emission tomography) (acetate PET, PET-PSMA, NAFL-PET) and CT / MRI is sufficient
Key exclusion criteria (7 listed)
- severe comorbidity which limit the further life expectancy of the patient to <5 years (opinion of the physician)
- PSA in PSA relapse> 10ng/ml
- Ongoing androgen deprivation at the time of study inclusion
- not been carried out local therapy
- no histological confirmation of prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal fractionated irradiation25*2 Gy (once a day, 5 days a week) | Radiation | normal fractionated irradiation |
| hypo fractionated irradiation3*10 Gy (once a day, 2-3 days a week) | Radiation | hypo fractionated irradiation |
Primary outcome
Late Toxicity at year 2 after ablatvie radiotherapy
Time frame: 24 months after therapy
The toxicity will be scored (CTCAE 4.03) at each follow up visit, the status will be recorded by clinical examination and radiological imaging.
5 secondary outcomes
Early toxicity
Time frame: until day 90 after start radiotherapy
Quality of life (QLQ-C30 and QLQ-PR25) during Follow-up
Time frame: 24 months after end of therapy
Local control of irradiated tumor manifestations
Time frame: 24 months after end of therapy
Therapy-free survival
Time frame: 24 months after end of therapy
PSA relapse-free survival
Time frame: 24 months after end of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Hölscher, Dr. principal investigator
Technische Universität Dresden, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Disease and Prostate Cancer, run by Technische Universität Dresden at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Toxicity at year 2 after ablatvie radiotherapy (time frame: 24 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.